| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2851124 | 67 | F | OR | 07/24/2025 |
FLU3 VARZOS |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
U8521AA 47N3Y |
Injection site pain; Injection site pain
Injection site pain; Injection site pain
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Patient reports that pain was initially dull and deep in the muscle, it has been getting worse star...
Patient reports that pain was initially dull and deep in the muscle, it has been getting worse starting first at the injection site and has spread down to the level of the elbow. It is continuous and patient has been unable to pinpoint what exacerbates it. Patient report multiple times per day using bio-freeze which helps for a less than an hour. As of yesterday patient has picked up gabapentin specifically for this pain.
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| 2851125 | 17 | F | ID | 07/24/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
TH9NR |
Interchange of vaccine products
Interchange of vaccine products
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Patient was given Trumenba in the past, but was given Bexsero booster.
Patient was given Trumenba in the past, but was given Bexsero booster.
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| 2851126 | 30 | F | TX | 07/24/2025 |
PNC21 |
MERCK & CO. INC. |
Z002626 |
Feeling hot, Pain
Feeling hot, Pain
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Patient stated she had warmth and pain
Patient stated she had warmth and pain
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| 2851127 | 16 | F | 07/24/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
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Dizziness postural, Headache, Injection site rash, Injection site swelling, Rash...
Dizziness postural, Headache, Injection site rash, Injection site swelling, Rash erythematous
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She received her MCV4 and MenB vaccines and the next day developed a red bump on her arm at the sit...
She received her MCV4 and MenB vaccines and the next day developed a red bump on her arm at the site of injection. The redness became more pronounced and swelling developed. She has also had some frontal headache and dizziness upon standing since then. Today the swelling and redness have lessened. No fever, vomiting, diarrhea, difficulty breathing, LOC, swelling of lips or rest of body. She has never had a vaccine reaction before.
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| 2851128 | 65 | M | 07/24/2025 |
IPV MNQ |
SANOFI PASTEUR SANOFI PASTEUR |
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Wrong product administered; Wrong product administered
Wrong product administered; Wrong product administered
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Patient came in requesting pneumococcal vaccine but was given meningococcal vaccine due to misunders...
Patient came in requesting pneumococcal vaccine but was given meningococcal vaccine due to misunderstanding/language barrier between assisting technicians and pharmacist and patient. Patient returned to pharmacy the next day stating he may have gotten wrong vaccine, explained again what he came in for and it was discovered he meant to receive the pneumococcal vaccine. The patient reported no vaccine issues from meningococcal just that he would like pneumococcal, which was provided to him.
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| 2851129 | 52 | F | OR | 07/24/2025 |
PNC21 |
MERCK & CO. INC. |
Z004301 |
Rash pruritic
Rash pruritic
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Itchy rash surrounding
Itchy rash surrounding
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| 2851130 | 68 | M | FL | 07/24/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
u8764cb u8764cb |
Amnesia, Chills, Disorientation, Erythema, Fatigue; Feeling hot, Gait inability,...
Amnesia, Chills, Disorientation, Erythema, Fatigue; Feeling hot, Gait inability, Mobility decreased, Pyrexia
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Pt started to have adverse events 3 hours after vaccination including extreme fatigue, fever, and ch...
Pt started to have adverse events 3 hours after vaccination including extreme fatigue, fever, and chills. He says he never did take his temperature, but was "extremely hot" and his face was red. He reports becoming extremely disoriented and could not walk or move from bed. He reports that he has no memory from Saturday night to Sunday afternoon. He also reports he could not eat or take any medications from Saturday night to Monday morning. By day 3 he was feeling "back to normal."
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| 2851131 | 50 | F | MS | 07/24/2025 |
PNC21 TDAP VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Injection site erythema, Injection site pain, Injection site warmth; Injection s...
Injection site erythema, Injection site pain, Injection site warmth; Injection site erythema, Injection site pain, Injection site warmth; Injection site erythema, Injection site pain, Injection site warmth
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Severe redness below the injection site of the Capvaxive comprising half the circumference of the ri...
Severe redness below the injection site of the Capvaxive comprising half the circumference of the right arm (approximately 3 ? x 5 ?) in addition to excessive warmth and pain to the affected area. Treated with daily Aleve or Ibuprofen and still unresolved after 72 hours.
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| 2851132 | 62 | F | CA | 07/24/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Z002626 Z002626 |
Chills, Fatigue, Headache, Injection site erythema, Injection site pain; Injecti...
Chills, Fatigue, Headache, Injection site erythema, Injection site pain; Injection site swelling, Injection site warmth, Pyrexia
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Fever, chills, headache, fatigue, redness, warmth, pain and swelling at injection site
Fever, chills, headache, fatigue, redness, warmth, pain and swelling at injection site
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| 2850772 | TX | 07/23/2025 |
VARCEL |
MERCK & CO. INC. |
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Incomplete course of vaccination, No adverse event
Incomplete course of vaccination, No adverse event
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HCP called and reported missed doses for VARIVAX and MMR-II.; No additional AE; first dose of VARIVA...
HCP called and reported missed doses for VARIVAX and MMR-II.; No additional AE; first dose of VARIVAX on 16NOV2024 and their first dose of MMR-II on 11NOV2024; This spontaneous report was received from a medical student and refers to a 55-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 11-Nov-2024, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), solution for injection, the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, route of administration, lot # and expiration date were not reported), administered as prophylaxis. Afterwards, on 16-Nov-2024, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), solution for injection, the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, route of administration, lot # and expiration date were not reported), administered as prophylaxis (Inappropriate schedule of product administration). On an unknown date, the patient missed doses for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (Product dose omission issue). No adverse event. Batch/Lot number is being requested and will be submitted if received.
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| 2850773 | F | TX | 07/23/2025 |
HPVX HPVX HPVX HPVX HPVX HPVX HPVX HPVX HPVX HPVX |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Abdominal discomfort, Abdominal distension, Abdominal pain, Abdominal pain upper...
Abdominal discomfort, Abdominal distension, Abdominal pain, Abdominal pain upper, Amenorrhoea; Autonomic nervous system imbalance, Back pain, Cold sweat, Decreased appetite, Dizziness; Epistaxis, Fatigue, Headache, Hot flush, Musculoskeletal chest pain; Nausea, Ocular discomfort, Pain, Postural orthostatic tachycardia syndrome, Vision blurred; Vomiting; Abdominal discomfort, Abdominal distension, Abdominal pain, Abdominal pain upper, Amenorrhoea; Autonomic nervous system imbalance, Back pain, Cold sweat, Decreased appetite, Dizziness; Epistaxis, Fatigue, Headache, Hot flush, Musculoskeletal chest pain; Nausea, Ocular discomfort, Pain, Postural orthostatic tachycardia syndrome, Vision blurred; Vomiting
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dysautonomia and Postural Orthostatic Tachycardia Syndrome (POTS); Information has been received fr...
dysautonomia and Postural Orthostatic Tachycardia Syndrome (POTS); Information has been received from a lawyer, regarding a case in litigation and concerning a 14-year-old (reported as adult) female patient. No information concerning the pt's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, route, anatomical location, lot number and expiration date were not provided). On an unknown date, the patient received the second dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, route, anatomical location, lot number and expiration date were not provided) for preventing cancer. On an unknown date, after receiving the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccination, the pt began to suffer from headaches, dizziness, lightheadedness, nose bleeds, hot flashes, cold sweats, nausea, fatigue, loss of menses, loss of appetite, gastrointestinal discomfort, which includes bloating after eating, stomach pains and cramping. The pain radiated to her back. The pt sought medical treatment for abdominal pain, nausea, cold sweats, lightheadedness, dizziness on/off for one month, and bloating after eating, and during one visit, it was noted that she had been without a menses for months. Prior to the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccine, her menstrual cycle was normal and present. She had tried various medications to help regulate her body, nothing has worked. During one appointment, the records state "Rib pain and random times of dizziness, hot flashes, blurred vision, pressure behind eyes and nausea. Patient vomited once "yesterday" and have been to multiple specialists for the rib pain, have not gotten any answers to what is going on with patient. Based upon her chronic and severe post- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) symptoms, Matter has been diagnosed with various medical conditions, including but not limited to, dysautonomia and Postural Orthostatic Tachycardia Syndrome (POTS). It was mentioned that although her symptoms started after her first vaccination, everything worsened after the second Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccination. The pt contended that her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune, and neurological, injuries and all of which were caused by Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) or otherwise linked to her Gardasil-induced autoimmune disorder and additionally continue to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. the patient experienced dysautonomia and Postural Orthostatic Tachycardia Syndrome (POTS). At the reporting time, the patient had not recovered from Postural Orthostatic Tachycardia Syndrome (POTS). The lawyer considered the event of Postural Orthostatic Tachycardia Syndrome (POTS) to be related to Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). The lawyer considered the event Postural Orthostatic Tachycardia Syndrome (POTS) to be medically significant and disabling/incapacitating.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-07-16 , MNSC number : , CLIC number : , ESTAR number : LEGCOL , IRMS number : 68936 , Central date : 2025-07-14 , Classification : DMC, Attachment description : Legal , Safety case number :
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| 2850774 | OH | 07/23/2025 |
VARCEL |
MERCK & CO. INC. |
X017486 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No additional AE; expired dose of VARIVAX was administered; This spontaneous report was received fro...
No additional AE; expired dose of VARIVAX was administered; This spontaneous report was received from an Advanced Practice Registered Nurse (APRN) on 18-Jul-2025 and refers to a patient of unknown age and gender. The patient's medical history concurrent conditions and concomitant therapies were not reported. On 17-Jul-2025, the patient was vaccinated with an expired dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), Injection (lot #X017486, expiration date: 25-Jun-2025), dose: 0.5 mL administered by Subcutaneous route (dose number were unspecified) for Prophylaxis (Expired product administered). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) dose: 0.5 mL administered by Subcutaneous route (dose number, lot# and expiration date were unspecified ) for Prophylaxis, on 17-JUL-2025. No additional adverse event was reported.
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| 2850775 | F | IN | 07/23/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Incomplete course of vaccination, No adverse event
Incomplete course of vaccination, No adverse event
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First Dose of HEPLISAV-B in February 2025 Has Not Received Next Dose; Initial report received on 07-...
First Dose of HEPLISAV-B in February 2025 Has Not Received Next Dose; Initial report received on 07-Jul-2025. A pharmacist reported that a 58-year-old female received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in Feb-2023 and has not received another dose yet. No medical history or concomitant medications were reported. In Feb-2023, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available). On 07-Jul-2025, approximately 2 years and 5 months after receiving the first dose HEPLISAV-B, the reporter contacted medical information to inquire if the HEPLISAV-B series needed to be restarted. No adverse reactions were reported. The reporter declined to provide further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2850776 | F | OR | 07/23/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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Incomplete course of vaccination; This non-serious case was reported by a nurse via call center repr...
Incomplete course of vaccination; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old female patient who did not receive HBV (Engerix B) for prophylaxis. Previously administered products included RECOMBIVAX (received on 14th June 2014). Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b). On an unknown date, the patient did not receive the 2nd dose of Engerix B. The patient experienced incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 27-JUN-2025 The reporter called to ask they had a worker that received a Hepatitis B vaccine on twenty-fourteen (with a non-GlaxoSmithKline vaccine), and recently a ENGERIX-B on May twenty twenty-five. The reporter asked if they must administer a complete series for GlaxoSmithKline vaccine or when could they administer the third required dose for this patient. The reporter asked was there any advice on this. The vaccination date, vaccine detail and patient demographics were obtained in this call. No further information was obtained in this call. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. Till the time of reporting, the patient did not receive the 2nd dose of Engerix B, which led to incomplete course of vaccination.
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| 2850777 | 34 | F | AL | 07/23/2025 |
MEN |
UNKNOWN MANUFACTURER |
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No adverse event, Off label use
No adverse event, Off label use
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Menquadfi prescribed with off labeldiagnosis Myasthenia gravis without (acute) exacerbation (with no...
Menquadfi prescribed with off labeldiagnosis Myasthenia gravis without (acute) exacerbation (with no reported adverse event); Initial information received on 18-Jul-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 34 years old female patient who was prescribed Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] for myasthenia gravis without (acute) exacerbation with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient was prescribed 0.5 (units unspecified) dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection, (unknown strength and expiry date) lot number not reported via intramuscular route in unknown administration site for myasthenia gravis without (acute) exacerbation with no reported adverse event (Product prescribing issue). Information regarding batch number corresponding to the one at time of event occurrence was requested. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2850787 | KY | 07/23/2025 |
DTAP HEPA PNC13 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH |
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Abnormal behaviour, Hyporesponsive to stimuli, Somnolence; Abnormal behaviour, H...
Abnormal behaviour, Hyporesponsive to stimuli, Somnolence; Abnormal behaviour, Hyporesponsive to stimuli, Somnolence; Abnormal behaviour, Hyporesponsive to stimuli, Somnolence
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July 1, 2025 (Morning): Baby received routine vaccinations at facility Approximately 1 hour after va...
July 1, 2025 (Morning): Baby received routine vaccinations at facility Approximately 1 hour after vaccination: Baby became unusually sleepy and took a nap. Next 12 hours: - Baby was very difficult to wake - Did not fully open eyes or respond normally - Pupils were observed changing size ? dilating and constricting - Baby did not engage in normal feeding behavior - At one point, baby drank through a straw and ate a popsicle with eyes closed - Never fully woke or responded to voices or touch during this time - No fever, rash, or vomiting was noted at the time and all vital signs were normal After approximately 12 hours: Baby slowly returned to normal alertness and began acting more like himself. Current Status (as of today): Baby has returned to normal behavior. No known lasting effects, but concern remains about possible neurological involvement due to: - Prolonged unresponsiveness - Pupil changes - Feeding with eyes closed - Lack of normal arousal for 12 hours
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| 2850797 | 07/23/2025 |
VARZOS VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK |
Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administ...
Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administered, Herpes zoster, Vaccination failure
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Suspected vaccination failure; had a horrendous case of them; I had all 3 shots; This serious case w...
Suspected vaccination failure; had a horrendous case of them; I had all 3 shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had a horrendous case of them) and extra dose administered (Verbatim: I had all 3 shots). The outcome of the vaccination failure and shingles were not reported and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 17-JUL-2025 This case was reported by a patient via interactive digital media. The patient had all 3 shots and had a horrendous case of them. The patient received 3 shots of Shingles vaccine, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles (Dose 1, 2 & 3)
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| 2850798 | F | WV | 07/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Mobility decreased, Musculoskeletal stiffness
Mobility decreased, Musculoskeletal stiffness
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presented problems with her arm/ lifting her arm, locked to a certain point; Locked arm (tightness) ...
presented problems with her arm/ lifting her arm, locked to a certain point; Locked arm (tightness) after Shingrix first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a female patient who received Herpes zoster (Shingrix) for prophylaxis. In JAN-2025, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injected limb mobility decreased (Verbatim: presented problems with her arm/ lifting her arm, locked to a certain point) and muscle tightness (Verbatim: Locked arm (tightness) after Shingrix first dose). The outcome of the injected limb mobility decreased was not reported and the outcome of the muscle tightness was unknown. It was unknown if the reporter considered the injected limb mobility decreased and muscle tightness to be related to Shingrix. It was unknown if the company considered the injected limb mobility decreased and muscle tightness to be related to Shingrix. Additional Information: GSK Receipt Date: 11-JUL-2025 A pharmacist wanted to know if Shingrix second dose could be administered anywhere else than the arm, given that with the first dose the patient presented problems with her arm, lifting her arm, locked to a certain point in 2025. No AE (adverse event) shared by the HCP (health care professional) other than patient's gender because that first dose was given in another facility of which he did not know the zip code.
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| 2850799 | NY | 07/23/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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second dose was given January 22, 2025.; This non-serious case was reported by a nurse via sales rep...
second dose was given January 22, 2025.; This non-serious case was reported by a nurse via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (The patient received their first dose of bexsero September 10th 2024). On 22-JAN-2025, the patient received the 2nd dose of Bexsero. On 22-JAN-2025, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: second dose was given January 22, 2025.). The outcome of the drug dose administration interval too short was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-JUL-2025 Registered nurse reported that the patient received their first dose of Bexsero September 10th, 2024, and the second dose was given January 22, 2025, which led to drug dose administration interval too short. Reporter questioned that did the patient need a third dose. Ongoing, did patients who receive a second dose before the 6th month timeframe, should they get a 3rd dose.
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| 2850800 | 8 | CA | 07/23/2025 |
DTAP |
SANOFI PASTEUR |
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No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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daptacel given to an 8 yr old with no reported ae; Initial information received on 18-Jul-2025 regar...
daptacel given to an 8 yr old with no reported ae; Initial information received on 18-Jul-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 8 years old and unknown gender patient who received Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site, with no reported ae (product administered to patient of inappropriate age) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence was requested. Reportedly, states that a child came in for a physical and they were delayed on their vaccinations, so they had to catch this child up. In May they were 7 years and 11 months, and she said that the patient's birthday is XXXX and they came in on 13MayxxXX. She states that she knows the recommendation is Tdap after 7 years of age on a delayed schedule. She states that the patient was just shy of being an 8-yearold in a week or 10 days. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2850801 | 07/23/2025 |
DTAP |
SANOFI PASTEUR |
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No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Administration of Daptacel to a patient outside the labeled age range with no reported adverse event...
Administration of Daptacel to a patient outside the labeled age range with no reported adverse event; Initial information received on 18-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient with unknown age and gender who was administered to Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] outside the labeled age range with no reported adverse event The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunisation and administered outside the labeled age range with no reported adverse event (product administered to patient of inappropriate age) (latency same day). Reportedly, they wanted to know that DTaP vaccine (assume it is DAPTACEL)administered to a patient outside of the recommended age range. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2850802 | F | PA | 07/23/2025 |
PPV PPV |
MERCK & CO. INC. MERCK & CO. INC. |
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Injection site erythema, Injection site induration, Injection site mass, Injecti...
Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus, Injection site swelling; Nausea, Pain in extremity, Pyrexia, Restlessness
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I received the Pneumovax virus on June 19th. Above and beyond the typical arm hurt of many vaccines ...
I received the Pneumovax virus on June 19th. Above and beyond the typical arm hurt of many vaccines this one had a big red patch approximately 8 in by 5 in covering my entire upper arm until Wednesday June 26th. The area was red, swollen and itchy. Although the redness has diminished, there is still itchiness. In the direct area where the vaccine was inserted there is a very hard lump. Additional side effects from this vaccine include nausea, low-grade fever, and general feeling of unsettledness for 4 days post vaccine.
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| 2850803 | 8 | M | NC | 07/23/2025 |
PPV RSV |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Blood test, Cellulitis, Respiratory syncytial virus infection; Blood test, Cellu...
Blood test, Cellulitis, Respiratory syncytial virus infection; Blood test, Cellulitis, Respiratory syncytial virus infection
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Yes, he was hospitalized on June 15-17th. Vaccine reactions (pneumococcal) with cellulitis and RSV. ...
Yes, he was hospitalized on June 15-17th. Vaccine reactions (pneumococcal) with cellulitis and RSV. They are concerned he has CVID. He has had bloodwork. Waiting to see immunologist and for vaccine titers.
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| 2850804 | 91 | F | MT | 07/23/2025 |
COVID19 COVID19 COVID19 PNC21 PNC21 PNC21 |
MODERNA MODERNA MODERNA MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
8081260 8081260 8081260 Y019158 Y019158 Y019158 |
Dizziness postural, Dysarthria, Fatigue, Frequent bowel movements, Injected limb...
Dizziness postural, Dysarthria, Fatigue, Frequent bowel movements, Injected limb mobility decreased; Injection site pain, Mental impairment, Moaning, Muscular weakness, Nausea; Presyncope, Slow speech; Dizziness postural, Dysarthria, Fatigue, Frequent bowel movements, Injected limb mobility decreased; Injection site pain, Mental impairment, Moaning, Muscular weakness, Nausea; Presyncope, Slow speech
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Received Capvaxive and Covid Vaccinations. Pain in left arm during administration, which worsened th...
Received Capvaxive and Covid Vaccinations. Pain in left arm during administration, which worsened through the night and could not lift arm next morning. Upon awaking, stood to go to the bathroom and felt dizzy and almost passed out. Has excessive bowel movement, but not diarrhea. Went to sit in living area, speech was slow and slurred, unable to think or process thoughts. Moaning due to nausea. Tried to speak with Daughter on the phone, who thought a stroke and called EMS. Fire Department arrived and vital signs were normal. neurological assessment for stroke was done and no symptoms of stroke were noted. Fire Department cleared the on route Ambulance and family transported to local ER. Upon arrival, vital signs again were taken and normal. ER Physician assessed and treated with Zofran for nausea and Tylenol. Released and sent home. Upon returning home, slept most of the day and through the night. Since having had worsening leg weakness and fatigue.
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| 2850805 | F | NY | 07/23/2025 |
VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK UNK UNK |
Arthralgia, Coordination abnormal, Dyspnoea, Fatigue, Gait disturbance; Muscular...
Arthralgia, Coordination abnormal, Dyspnoea, Fatigue, Gait disturbance; Muscular weakness, Musculoskeletal stiffness, Myalgia, Neuropathy peripheral, Pyrexia; Tachycardia, Vaccination site pain; Asthenia, Feeling of despair, Insomnia, Loss of personal independence in daily activities, Mobility decreased; Neuropathy peripheral, Pain, Pyrexia, Tachycardia; Arthralgia, Coordination abnormal, Dyspnoea, Fatigue, Gait disturbance; Muscular weakness, Musculoskeletal stiffness, Myalgia, Neuropathy peripheral, Pyrexia; Tachycardia, Vaccination site pain; Asthenia, Feeling of despair, Insomnia, Loss of personal independence in daily activities, Mobility decreased; Neuropathy peripheral, Pain, Pyrexia, Tachycardia
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I received a shingles vaccine on 5/21/25. I had the expected vaccine site soreness, fatigue, and mus...
I received a shingles vaccine on 5/21/25. I had the expected vaccine site soreness, fatigue, and muscle aches for several days. Then I developed tachycardia, fever, and shortness of breath, intense pain in my joints, stiffness and weakness in my upper back, knees and elbows, extreme difficulty walking/mobilizing/coordinating, searing intense neuropathy in my hands and feet extending above the wrist and ankle. It is 7/4/25 and the neuropathy is still present and excruciating.
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| 2850806 | M | NM | 07/23/2025 |
MMR |
UNKNOWN MANUFACTURER |
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Emotional distress, Wrong product administered
Emotional distress, Wrong product administered
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On June 24, 2025, my minor son was scheduled to receive the meningitis vaccine at pharmacy. However,...
On June 24, 2025, my minor son was scheduled to receive the meningitis vaccine at pharmacy. However, due to a critical administration error, he was given the MMR (measles, mumps, rubella) vaccine instead. This was discovered only after the appointment when reviewing the pharmacy receipt. The pharmacy later confirmed the error. We are currently monitoring our son's health for any side effects. The incident caused significant emotional distress and raises serious concerns about vaccine verification protocols.
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| 2850807 | 40 | F | 07/23/2025 |
HPV9 |
MERCK & CO. INC. |
Y005835 |
Cutaneous calcification, Nodule, Sensation of foreign body, Ultrasound scan abno...
Cutaneous calcification, Nodule, Sensation of foreign body, Ultrasound scan abnormal
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First Human Papillomavirus 9-valent vaccine given on 5/8/25. Patient developed firm nodule of right...
First Human Papillomavirus 9-valent vaccine given on 5/8/25. Patient developed firm nodule of right arm of vaccine that has persisted. US of area shows a "shadowing echo in the region of concern right upper forearm corresponding to palpable abnormality measuring 7 x 4 x 4 mm suggesting calcification or other foreign body". NDC was 0006-4121-01
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| 2850808 | 56 | F | 07/23/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
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Fatigue, Incorrect route of product administration, Injection site erythema, Inj...
Fatigue, Incorrect route of product administration, Injection site erythema, Injection site induration, Injection site mass; Injection site pain, Injection site warmth, Muscular weakness
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CAPVAXIVE was administered subcutaneously instead of intramuscularly. Soreness, redness with hot/war...
CAPVAXIVE was administered subcutaneously instead of intramuscularly. Soreness, redness with hot/warm to touch, lump/harden on the arm around the injection site, fatigue, and weakness in legs. Then readiness hot/arm to touch has kept expanding further away from the injection site and the lump/harden area won't go away after a few days. This condition has been ongoing since late Wednesday, July 16, 2025 when this vaccine was administered.
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| 2850809 | 60 | F | MA | 07/23/2025 |
COVID19 |
MODERNA |
004C221A |
Eustachian tube disorder, Skin hypopigmentation
Eustachian tube disorder, Skin hypopigmentation
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Started losing pigment in my right ankle. Has now spread to my right foot and left ankle.
Started losing pigment in my right ankle. Has now spread to my right foot and left ankle.
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| 2850810 | 0.5 | M | CO | 07/23/2025 |
DTAPHEPBIP HIBV PNC20 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH |
9359N Y016315 LX4483 |
Dyskinesia, Electroencephalogram, Magnetic resonance imaging; Dyskinesia, Electr...
Dyskinesia, Electroencephalogram, Magnetic resonance imaging; Dyskinesia, Electroencephalogram, Magnetic resonance imaging; Dyskinesia, Electroencephalogram, Magnetic resonance imaging
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Within 2 weeks of his 2 month vaccines pt started with abnormal movements, no definitive diagnosis. ...
Within 2 weeks of his 2 month vaccines pt started with abnormal movements, no definitive diagnosis. Movements stopped 1 month later. Parents decline further vaccines
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| 2850850 | MO | 07/23/2025 |
MMRV |
MERCK & CO. INC. |
Y019171 |
Product storage error
Product storage error
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No additional AE/no PQC; stored. This case pertains to one patient who received improperly stored PR...
No additional AE/no PQC; stored. This case pertains to one patient who received improperly stored PROQUAD on 06/10/2025; Information has been received from a nurse and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 10-Jun-2025, the patient vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (lot #Y019171, expiration date: 18-May-2026, 0.5 mL, frequency, strength, and route were unknown) for prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were unknown). No symptom was reported. No additional event was reported. The stored temperature was 6.3 Fahrenheit (F). The time frame was 16 minutes. There was no previous temperature excursion. This is one of 16 linked cases received from the same reporter.
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| 2850851 | NM | 07/23/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y015100 |
Expired product administered, No adverse event; Expired product administered, No...
Expired product administered, No adverse event; Expired product administered, No adverse event
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No additional AE; inadvertent administration of expired VARIVAX to a patient on 09JUN2025. VARIVAX u...
No additional AE; inadvertent administration of expired VARIVAX to a patient on 09JUN2025. VARIVAX underwent a temperature excursion on 05MAR2025 which resulted in the vaccine being "supported and viable" until 05JUN2025; This spontaneous report was received from a Pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 09-Jun-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection (valid lot #Y015100, expiration date was provided and confirmed as: 06-Sep-2026) for prophylaxis (exact dose, dose number, anatomical location, and route of administration were not provided). The suspect vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), Solution for injection (expiration date, and lot # were not reported). The patient experienced inadvertent administration of expired Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) on 09-JUN-2025 (conflicting information, expiration date was correct). Suspect vaccine underwent a temperature excursion (on 05-MAR-2025): 36 Fahrenheit (F) to 46F for 286 hours 42 minutes 0 seconds, which resulted in the vaccine being "supported and viable" until 05-JUN-2025 (discrepancy) (product storage error). No additional adverse event (AE) was reported (no adverse event).
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| 2850852 | 24 | F | NJ | 07/23/2025 |
HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Anhidrosis, Anxiety, Asthenia, Autonomic nervous system imbalance, Brain fog; Ch...
Anhidrosis, Anxiety, Asthenia, Autonomic nervous system imbalance, Brain fog; Chest pain, Dry eye, Dry mouth, Dyspnoea, Dyspnoea exertional; Fatigue, Headache, Heart rate increased, Impaired work ability, Insomnia; Loss of personal independence in daily activities, Migraine, Palpitations, Sinus tachycardia, Sjogren's syndrome; Small fibre neuropathy, Syncope, Tachycardia, Vitamin B12 deficiency, Vitamin D deficiency; Vulvovaginal dryness; Anhidrosis, Anxiety, Asthenia, Autonomic nervous system imbalance, Brain fog; Chest pain, Dry eye, Dry mouth, Dyspnoea, Dyspnoea exertional; Fatigue, Headache, Heart rate increased, Impaired work ability, Insomnia; Loss of personal independence in daily activities, Migraine, Palpitations, Sinus tachycardia, Sjogren's syndrome; Small fibre neuropathy, Syncope, Tachycardia, Vitamin B12 deficiency, Vitamin D deficiency; Vulvovaginal dryness; Anhidrosis, Anxiety, Asthenia, Autonomic nervous system imbalance, Brain fog; Chest pain, Dry eye, Dry mouth, Dyspnoea, Dyspnoea exertional; Fatigue, Headache, Heart rate increased, Impaired work ability, Insomnia; Loss of personal independence in daily activities, Migraine, Palpitations, Sinus tachycardia, Sjogren's syndrome; Small fibre neuropathy, Syncope, Tachycardia, Vitamin B12 deficiency, Vitamin D deficiency; Vulvovaginal dryness
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Sjogren's disease; sinus tachycardia; dysautonomia; small fiber neuropathy; Vitamin D and B12 d...
Sjogren's disease; sinus tachycardia; dysautonomia; small fiber neuropathy; Vitamin D and B12 deficiency; Vitamin B12 deficiency; tachycardia; Information has been received from a lawyer regarding a case in litigation referring to an adult female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. Prior to the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccinations, the patient had no health issues such as sinus tachycardia, dysautonomia, small fiber neuropathy, Sjogren's disease, and vitamin D deficiency. She was an active athlete in high school and college, she enjoyed playing volleyball, socializing and working out. On an unknown date, the patient was vaccinated with first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), (dose, lot # and expiration date were not reported) for preventing cervical cancer. The patient was 24 years old when she received three doses of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). On an unknown date, following the first Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccine, the patient experienced an increase in heart rate. Activities she was able to do in the past became difficult. She started to experience shortness of breath with simple everyday tasks like walking her dog, walking to class, or going up the stairs at her apartment. The patient sought treatment from multiple physicians, and she underwent extensive testing. The patient was ultimately diagnosed with sinus tachycardia by physician A; tachycardia by physician B; dysautonomia, small fiber neuropathy, and Sjogren's disease by physician C; and Vitamin D and B12 deficiency by physician D. To manage her illnesses, each morning began with a regimen of medicines: Lidocaine-prilocaine Cream (applied twice daily), Ergocalciferol 1,250mcg, Fluconazole 150mg (taken once per week), Lidocaine 5% cream, Alprazolam 02.5mg, Ketorolac 10mg, Conjugated Estrogens 0.625mg (taken three times weekly), Methylprednisolone (taper pack), Propranolol 60mg, Duloxetine 30mg, Hydroxychloroquine 200mg, and Pilocarpine 5mg) taken three times daily). The patient regularly visited multiple doctors and underwent routine blood work. As the months progressed, so did the patient's symptoms. She could no longer function in the same capacity as before. Her school experience and career had suffered. She was now a lawyer, but she had to request an extension and accommodation to take the bar exam later because of her health condition. Exercise was no longer enjoyable because of her increased heart rate and tiredness. What might be a common cold for others could escalate into a severe infection for her, necessitating intensive treatment. Her immunologist recommended jobs with minimal contact with others, presenting a significant challenge as a lawyer, affecting both her daily life and income. Simple outings required meticulous planning and precautions, from carrying hand sanitizer everywhere to avoid peak flu seasons and wearing masks in airports. Fatigue was her constant battle. It was a silent struggle, invisible to those who do not understand the daily battles she faced. The patient always dreamed of having a large family, but now she was concerned about having children. Fetal lupus or congenital heart block were potential risks for babies born to mothers with Sjogren's disease. The patient's life changed from a normal, healthy, active young woman to living with a serious immune deficiency. The patient was navigating a constant battle between health and illness. Simple tasks that others took for granted, like going to crowded places or shaking hands, became calculated risks. Her injuries from the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccinations were ongoing and she would require constant treatment and medication for the rest of her life, as there was no cure for her health conditions. The patient was seen by multiple physicians and specialists for her complaints of neuropathy, brain fog, fainting, fatigue, heart palpitations, chest pain, tachycardia, dry eyes, mouth and vaginal dryness, anxiety, shortness of breath while exercising, headaches and migraines, trouble sleeping, weakness, and she cannot produce sweat. Based upon her chronic and severe post-Gardasil symptoms, the patient had been diagnosed with various medical conditions, including but not limited to, sinus tachycardia, dysautonomia, small fiber neuropathy, Sjogren's disease, and vitamin deficiency. The patient contended that her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to, sinus tachycardia, dysautonomia, small fiber neuropathy, Sjogren's disease, and vitamin deficiency, brain fog, fainting, fatigue, heart palpitations, chest pain, tachycardia, dry eyes, mouth and vaginal dryness, anxiety, shortness of breath while exercising, headaches and migraines, insomnia, weakness, and she could not produce sweat, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) or otherwise linked to her Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of company's fraudulent, false, and misleading statements, omissions, and conduct concerning the safety and efficacy of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), the patient had suffered and continued to suffer severe and permanent physical injuries and associated symptomology and had suffered severe and permanent emotional injuries, including pain and suffering. The patient also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer and future symptoms and harms associated with her autoimmune disease and other injuries caused by Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). As a direct and proximate result of their Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)-induced injuries, the patient had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she would continue to incur these losses and expenses in the future. The outcome was considered as not recovered. The lawyer considered all the events to be related to Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). The lawyer considered all the events to be disabling.
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| 2850853 | TX | 07/23/2025 |
MMRV |
MERCK & CO. INC. |
Y018154 |
Syringe issue, Underdose
Syringe issue, Underdose
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AE was filed since she stated that a patient missed a dose.; PFS leaked while injecting diluent into...
AE was filed since she stated that a patient missed a dose.; PFS leaked while injecting diluent into the PROQUAD vial; PFS leaked while injecting diluent into the PROQUAD vial; This spontaneous report was received from a medical assistant and a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-Jul-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose, route of administration, lot #Y018154, expiration date: 29-Apr-2026) as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # 2050911, expiration date: 11-Feb-2027) pre-filled syringe (PFS). It was reported that PFS leaked while injecting diluent into the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) vial (Syringe issue, Poor quality device used). She wasn't completely sure but she thought that leaking was at the Luerlock area. When she pulled out the reconstituted solution using a different syringe and needle, she only got 0.2ml so she put the solution back into the vial. She stated that a patient missed a dose (Product dose omission issue). No further information was available. It was also reported that the needle was not supplied by Company and it was used to instill the diluent. different syringe and needle were used between adding the diluent to the vial and withdrawing the reconstituted product from the vial. No damage or issues with the shipping container, carton that contained the syringe undamaged on receipt, plastic syringe tray. N injury as a result of the breakage. The syringe or it parts was not exposed to the patient's bodily fluids.
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| 2850854 | F | 07/23/2025 |
RAB RAB RAB RAB |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR SANOFI PASTEUR |
Unknown Unknown Unknown Unknown |
Chest pain, Decreased appetite, Hallucination, Insomnia, Palpitations; Tinnitus,...
Chest pain, Decreased appetite, Hallucination, Insomnia, Palpitations; Tinnitus, Tremor; Chest pain, Decreased appetite, Hallucination, Insomnia, Palpitations; Tinnitus, Tremor
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hallucinations; chest pain; The patient got sick with like Insomnia; shaking really bad, like really...
hallucinations; chest pain; The patient got sick with like Insomnia; shaking really bad, like really bad tremors; Ringing in ears; Heart palpitations; The patient didn't eat any more; The patient got sick with like Insomnia; The patient pretty bad reaction; The patient received one dose of RabAvert and one dose of Imovax; Case reference number US-BN-2025-001178 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV25-1646) on 08-Jul-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date also reported as in Mar-2025, the patient received the first dose of RabAvert along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route, or site of administration for an unknown indication (explicitly coded 'interchange of vaccine products') On an unspecified date also reported as in Mar-2025, an unknown time from the vaccination with RabAvert, the patient received the second dose of the co-suspect vaccine Imovax (batch number: unknown) at an unknown dose, route, or site of administration for an unknown indication. On an unspecified date, an unknown time from the vaccination with RabAvert, the patient experienced pretty bad reaction, got sick with like insomnia, had some hallucinations, did not eat any more, had a lot of chest pain, started having heart palpitations, and shaking really badly, like really bad tremors. On an unspecified date, the patient experienced ringing in the ears and stuff like that. On an unspecified dates, as reported since March, the patient had been in and out of the hospital. At the time of the initial report, it was unknown if the patient had recovered from the events of hallucinations, 'insomnia', 'decreased appetite', chest pain, 'palpitations', 'tremor', 'sickness' and 'adverse reaction' and did not recover from event of ringing in ears, as reported and was still dealing with ringing in the ears and stuff like that. The reporter did not provide a seriousness assessment for the events of hallucinations, 'insomnia', 'decreased appetite', chest pain, 'palpitations', 'tremor', ringing in ears, 'sickness' and 'adverse reaction', however the events assessed serious due to seriousness criteria of hospitalization and evet of hallucinations was assessed as serious due seriousness criteria of medical significance. The reporter assessed the events of hallucinations, 'insomnia', 'decreased appetite', chest pain, 'palpitations', 'tremor', ringing in ears, 'sickness' and 'adverse reaction' as possibly related to the product RabAvert. No further information was provided.; Reporter's Comments: A female patient of unspecified age received the first dose of RabAvert for an unknown indication, and the second dose of the co-suspect vaccine Imovax, which is considered as interchange of vaccine products. On an unspecified date, an unknown time from the vaccination with RabAvert, the patient experienced serious events of bad reaction, got sick with like insomnia, had some hallucinations (medical significance), did not eat any more, had a lot of chest pain, started having heart palpitations, and shaking badly, like bad tremors (hospitalization). Decreased appetite is listed for RabAvert per CCDS v5 and unexpected per USPI, whilst palpitations is unlisted and expected. Hallucination, chest pain, insomnia, tremor and tinnitus are unlisted and unexpected. Illness, adverse reaction and interchange of vaccine products are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. The patient's co-suspect vaccination confounded the causality. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported events have been considered as related to RabAvert. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance and hospitalization.; Sender's Comments: A female patient of unspecified age received the first dose of RabAvert for an unknown indication, and the second dose of the co-suspect vaccine Imovax, which is considered as interchange of vaccine products. On an unspecified date, an unknown time from the vaccination with RabAvert, the patient experienced serious events of bad reaction, got sick with like insomnia, had some hallucinations (medical significance), did not eat any more, had a lot of chest pain, started having heart palpitations, and shaking badly, like bad tremors (hospitalization). Decreased appetite is listed for RabAvert per CCDS v5 and unexpected per USPI, whilst palpitations is unlisted and expected. Hallucination, chest pain, insomnia, tremor and tinnitus are unlisted and unexpected. Illness, adverse reaction and interchange of vaccine products are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. The patient's co-suspect vaccination confounded the causality. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported events have been considered as related to RabAvert. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance and hospitalization.
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| 2850855 | F | 07/23/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Chills, Pollakiuria
Chills, Pollakiuria
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fever 100.3; chills; excessive urination; This non-serious case was reported by a consumer and descr...
fever 100.3; chills; excessive urination; This non-serious case was reported by a consumer and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 09-MAY-2025, the patient received Shingles vaccine .5 ml. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: fever 100.3), chills (Verbatim: chills) and micturition disorder (Verbatim: excessive urination). The outcome of the fever, chills and micturition disorder were not resolved. It was unknown if the reporter considered the fever, chills and micturition disorder to be related to Shingles vaccine. It was unknown if the company considered the fever, chills and micturition disorder to be related to Shingles vaccine. Additional Information: GSK receipt date: 19-JUL-2025 The patient reported that after the Shingrix vaccine she experienced fever 100.3, chills and excessive urination. The patient had no previous medical history The expiry date of Shingles vaccine was unknown.
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| 2850856 | 07/23/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Blister, Erythema, Herpes zoster, Pain, Rash; Vaccination failure
Blister, Erythema, Herpes zoster, Pain, Rash; Vaccination failure
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Suspected vaccination failure; I got the vaccine and currently have the shingles; This serious case ...
Suspected vaccination failure; I got the vaccine and currently have the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included chickenpox (mild case in 20s). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the vaccine and currently have the shingles). The patient was treated with calamine. The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 16-JUL-2025 The case was received from a patient via interactive digital media. The patient got the vaccine and currently had the shingles. It was only on the patient's right upper arm in 3 areas and only hurt for 2 days once the areas started to blister. The patient put calamine lotion on it several times a day. It was starting to dry up now. The patient woke up Wednesday saw bumps and red areas thinking he/she was bitten by a bugs. Then it started looking like a rash the next day and the reporter realized it was the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2850857 | 07/23/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; got the shingles; This serious case was reported by a consumer via in...
Suspected vaccination failure; got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 14-JUL-2025 This case was reported by a consumer via interactive digital media. The reporter stated that everyone they knew, got shingles vaccine and got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
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| 2850858 | 07/23/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; had singles twice after the shot; This serious case was reported by ...
Suspected vaccination failure; had singles twice after the shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had singles twice after the shot). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 13-JUL-2025 This case was reported by a patient via interactive digital media. The patient had shingles twice after the Shingles shot This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2850859 | 3 | F | WA | 07/23/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
3397T |
Expired product administered
Expired product administered
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Havrix expired dose administration; This non-serious case was reported by a other health professiona...
Havrix expired dose administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received HAV (Havrix) (batch number 3397T, expiry date 30-NOV-2023) for prophylaxis. On 28-FEB-2025, the patient received Havrix. On 28-FEB-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Havrix expired dose administration). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 10-JUL-2025 A health care provider wanted to know if a dose of Havrix (lot 3397T) was expired when it was administered on 28 February 2025. The agent confirmed that it expired on 30th November 2023, which led to expired vaccine used and offered to give the information of the recommendations in this case, but she mentioned that only wanted to receive it via email. The presentation given was pediatric, thus the adverse event it's only for the expired dose administration. The health care professional mentioned that the vaccine could have been given in the facility.
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| 2850860 | F | SC | 07/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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longer interval between doses; This non-serious case was reported by a pharmacist via call center re...
longer interval between doses; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 29-NOV-2023). On an unknown date, the patient did not receive the 2nd dose of Shingrix.The patient experienced incomplete course of vaccination (Verbatim: longer interval between doses). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 15-JUL-2025 Pharmacist reported a patient received her first dose of Shingrix in 2023 and now wanted to come in to get a dose. Patient had not yet received second dose. The lot and expiration date of 1st dose was not available from healthcare professional. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2850861 | 53 | F | NC | 07/23/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
H39Z4 |
Underdose
Underdose
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she accidentally gave a pediatric dose of Engerix-B to an adult patient; she accidentally gave a ped...
she accidentally gave a pediatric dose of Engerix-B to an adult patient; she accidentally gave a pediatric dose of Engerix-B to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 53-year-old female patient who received HBV (Engerix B pediatric) (batch number H39Z4, expiry date 04-DEC-2025) for prophylaxis. Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b adulto). On 11-APR-2025, the patient received the 2nd dose of Engerix B pediatric. On 11-APR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: she accidentally gave a pediatric dose of Engerix-B to an adult patient) and adult use of a child product (Verbatim: she accidentally gave a pediatric dose of Engerix-B to an adult patient). The outcome of the accidental underdose and adult use of a child product were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-JUL-2025 The certified medical assistant explained she accidentally gave a pediatric dose of Engerix-B to an adult patient on 11th April 2025 which led to adult use of a child product and accidental underdose. The patient got a first dose of Engerix-B on 7th March 2025, it was the usual adult dose.
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| 2850862 | 6 | F | CO | 07/23/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
YC239 |
Expired product administered
Expired product administered
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Patient was given Infanrix that was 4 days expired; This non-serious case was reported by a other he...
Patient was given Infanrix that was 4 days expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-year-old female patient who received DTPa (Infanrix) (batch number YC239, expiry date 13-JUL-2025) for prophylaxis. On 17-JUL-2025, the patient received Infanrix. On 17-JUL-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Patient was given Infanrix that was 4 days expired). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 17-JUL-2025 The reporter mentioned that a patient was given Infanrix that was 4 days expired, which led to expired vaccine used Consent to follow up granted.
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| 2850863 | TX | 07/23/2025 |
PNC20 |
PFIZER\WYETH |
LN4931 |
Syringe issue
Syringe issue
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how you have to twist the little cap, it came off and I guess the glass from the Prevnar because it ...
how you have to twist the little cap, it came off and I guess the glass from the Prevnar because it broke off and it is stuck in the part where the needle goes in; The initial case was missing the following minimum criteria: Info not qualifying for AE reporting - Product Complaint: no indication that the consumer experienced an event under Product Prevnar 20. Upon receipt of follow-up information on 16Jul2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP from product quality group. This report involves pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LN4931, Expiration Date: 31Jul2026) for immunisation. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "how you have to twist the little cap, it came off and I guess the glass from the Prevnar because it broke off and it is stuck in the part where the needle goes in". The reporter considered "how you have to twist the little cap, it came off and i guess the glass from the prevnar because it broke off and it is stuck in the part where the needle goes in" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "how you have to twist the little cap, it came off and i guess the glass from the prevnar because it broke off and it is stuck in the part where the needle goes in" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Follow-up (16Jul2025): This is a spontaneous follow-up report received from product quality group. Updated information: reportability assessment.
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| 2850864 | F | CO | 07/23/2025 |
COVID19 VARZOS |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
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Vaccination site erythema; Vaccination site erythema
Vaccination site erythema; Vaccination site erythema
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Redness extending around the shot but not in the area of the spot/This lasted for about 1.5 weeks af...
Redness extending around the shot but not in the area of the spot/This lasted for about 1.5 weeks after the shot; This is a spontaneous report received from an Other HCP from a sales representative. An adult female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Jul2025 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 01Jul2025 as dose 1, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 02Jul2025, outcome "recovered", described as "Redness extending around the shot but not in the area of the spot/This lasted for about 1.5 weeks after the shot". Therapeutic measures were not taken as a result of vaccination site erythema. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2850865 | F | TX | 07/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Blood pressure measurement, Hypertension
Blood pressure measurement, Hypertension
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blood pressure high, real high; This is a spontaneous report received from a Consumer or other non H...
blood pressure high, real high; This is a spontaneous report received from a Consumer or other non HCP. A 57-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OZEMPIC; HUMIRA. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "blood pressure high, real high". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500086335 same patient/drug, different dose/event;
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| 2850866 | 1 | F | OH | 07/23/2025 |
VARCEL |
MERCK & CO. INC. |
Z008083 |
Crying, Injection site erythema, Injection site pain, Injection site swelling, I...
Crying, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
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within 10 min of receiving vaccine skin around injection site became red, swollen and warm to touch...
within 10 min of receiving vaccine skin around injection site became red, swollen and warm to touch, pt cried when touched. Given children's benadryl 1.25mg/kg within 30 min of receiving medication the swelling and redness were almost completely resolved
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| 2850867 | 0.17 | M | OH | 07/23/2025 |
RV5 RV5 |
MERCK & CO. INC. MERCK & CO. INC. |
Z007562 Z007562 |
Crying, Diarrhoea, Discomfort, Flatulence, Infant irritability; Mucous stools, P...
Crying, Diarrhoea, Discomfort, Flatulence, Infant irritability; Mucous stools, Pyrexia
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Per patient's mom 7/20/25 9:34am (4 days after vaccine): "Pt got his 2m shots on Wednesda...
Per patient's mom 7/20/25 9:34am (4 days after vaccine): "Pt got his 2m shots on Wednesday. Within hours he developed a fever and was very cranky-crying on and off all day/night and Thursday as well. He cried more those two days than he has in his 9 weeks of life! We gave him Tylenol as directed and that helped with his fever. Thursday night he was inconsolable for an hour or so and I almost called but he eventually passed out and I was awake holding him all night. He continues to seem to be uncomfortable. No more fever and less fussy, but since Wednesday night he has not slept for more than an hour at a time and it seems like his tummy is bothering him. He is very chill, otherwise I wouldn t be so concerned. He had been sleeping from 9pm-5am, so something is definitely not right since he won t lay down for more than an hour and he wakes up crying loudly, something he never did before. I feel like his tummy hurts because he thrashes and lifts up his legs and is much more gassy than usual. His poop seems more watery and deeper/brighter in color. Nothing in my diet has changed and I ve continued to nurse him on demand I expected a rough night or two but now it s been 4 nights." Per office visit 7/22/25: Very fussy and with fever for 1 day. Fussiness persisted, seemed to come in spells. And now with mucus stools, no blood.
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| 2850868 | 61 | F | 07/23/2025 |
PNC20 |
PFIZER\WYETH |
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Extra dose administered
Extra dose administered
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patient received 2nd prevnar20 vaccine
patient received 2nd prevnar20 vaccine
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| 2850869 | 12 | M | MI | 07/23/2025 |
MNQ MNQ TDAP TDAP |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
57h54 57h54 h4279 h4279 |
Fall, Loss of consciousness, Pulse absent, Respiratory arrest, Resuscitation; Sk...
Fall, Loss of consciousness, Pulse absent, Respiratory arrest, Resuscitation; Skin laceration, Wound closure; Fall, Loss of consciousness, Pulse absent, Respiratory arrest, Resuscitation; Skin laceration, Wound closure
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Patient went to check out after receiving both immunizations. Patient then passed out, fell backward...
Patient went to check out after receiving both immunizations. Patient then passed out, fell backwards and hit his head on a door handle and was knocked unconscious. Patient lost pulse and CPR was initiated by his provider. Patient had laceration in the back of his scalp. EMS was called, patient regained pulse and respirations. Once EMS arrived patient was transferred
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